Tag Archives: sofosbuvir

Quick Hits: New Breast Cancer Drugs Have Fewer Side Effects, Antidepressant Use in Pregnancy and Autism & More

A new class of oral drugs for treating the most common type of breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, appears to have fewer adverse events and side effects for most patients compared to other treatments. There are 2 CDK inhibitors currently on the market: Ibrance (palbociclib), approved in February 2015, and Kisqali (ribociclib), which was just approved in March. Both are used to treat hormone receptor-positive (HR+) metastatic breast cancer. A third CDK inhibitor, abemaciclib, is in late-stage development. Researchers examined all publicly available trials for the 3 drugs. The most common side effect was low white blood cells, a condition known as neutropenia that can lead to infection, though it was seen less in abemaciclib. However, neutropenia was usually temporary or resolved with a dose reduction. Other, more common side effects seen with the medications were diarrhea and fatigue. Less common side effects observed were nausea and alopecia (hair loss), though these were mild and treated through a dose reduction or a break from the drug. Posted July 14, 2017. Via The Oncologist.

Children exposed to antidepressants during pregnancy may have a slightly higher risk of developing autism than children of mothers with mental illness who didn’t receive the drugs. Researchers, however, stress that the absolute risk of autism was small, so the results should not be considered alarming. A team at the University of Bristol (UK) analyzed data from 254,610 individuals aged 4-17 of which 5,378 had autism. Of the 3,342 children exposed to antidepressants during pregnancy, 4.1% (136) had a diagnosis of autism compared with 2.9% (353) in 12,325 children not exposed to antidepressants whose mothers had a history of a psychiatric disorder. Researchers noted that overall, 95% of women who took antidepressants did not have a child with autism. An accompanying editorial noted that the results should not dissuade women with depression from using antidepressants in pregnancy since untreated depression can lead to “ substantial health consequences.” Posted July 19, 2017. Via The BMJ.

The FDA has approved a new hepatitis C (HCV) medication, Vosevi. The drug is actually a combination of two existing anti-viral treatments, sofosbuvir and velpatasvir (sold as Epclusa), and a new drug, voxilaprevir. Vosevi is for patients with HCV without liver disease (cirrhosis) or with a mild form of cirrhosis. Results from 2 late-stage trials demonstrated that 96-97% of patients who received Vosevi had no HCV detected in their blood 12 weeks after finishing treatment, an indication the infection has been cured. The most common side effects in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Posted July 18, 2017. Via FDA.

 

Alanna McCatty
Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.

Quick Hits: FDA Approves Drugs for Tardive Dyskinesia, Hep C; Sedatives and Pneumonia Risk

The FDA approved Ingrezza (valbenazine) to treat adults with tardive dyskinesia, a serious side effect characterized by involuntary movements in the face and extremities sometimes seen in patients who have been treated with antipsychotic medications. Ingrezza, the first drug approved for this condition, may itself cause unwanted side effects such as sleepiness and heart rhythm problems (QT prolongation). Patients with congenital long QT syndrome (abnormal heartbeat) should avoid taking this drug. Posted April 11, 2017. Via FDA.

The FDA has approved 2 hepatitis C (HCV) drugs, Sovaldi and Harvoni, for use in children ages 12 to 17. Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Some patients experienced reactivation of the hepatitis B virus (HBV) when treated with the drugs, resulting in serious liver problems or death. The FDA advises that all healthcare professionals screen all of their patients for evidence of current or prior HBV infection before starting treatment with Harvoni or Sovaldi. Posted April 7, 2017. Via FDA.

Sedatives such as Valium or Xanax may increase the risk for pneumonia in Alzheimer’s patients. Researchers reviewed data from nearly 50,000 Alzheimer’s patients in Finland. The patients’ average age was 80 and about two-thirds were women. The study, published in the CMAJ (Canadian Medical Association Journal), found that people with Alzheimer’s who took benzodiazepines were 30% more likely to develop pneumonia than those who weren’t given the sedatives. Posted April 10, 2017. Via CMAJ.

Alanna McCatty
Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.

Quick Hits: Safety Issues for Hep C Drugs, Breast Cancer Treatment Side Effects & More

More than 1,500 additional cases of liver injury have been discovered that are associated with the newest class of hepatitis C drugs. In October, the FDA first identified 24 cases involving safety issues related to the 9 new antiviral drugs for hepatitis C, including Harvoni (ledipasvir-sofosbuvir), Olysio (simeprevir) and Sovaldi (sofosbuvir). While these drugs appeared to lower the hep C virus to undetectable levels in the majority of patients, some of them experienced reactivation of hepatitis B that had serious health consequences, including liver transplant and death. An investigation by the Institute for Safe Medicine Practices of FDA adverse events data identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of liver injury. In a further 761 cases, the adverse event was failure of the antiviral drug against the virus. Posted January 25, 2017. Via ISMP.

Almost half of women undergoing treatment for breast cancer experience side effects. Researchers in a study asked 1,945 women with early-stage breast cancer about 7 treatment side effects: nausea and vomiting, diarrhea, constipation, pain, arm swelling, shortness of breath and breast skin irritation. About 45% reported at least one of the side effects was severe or very severe. And when women got chemotherapy, the risk of severe side effects doubled. However, when chemo was conducted with radiation, the odds of severe side effects were just 30% higher. Posted January 24, 2017. Via Cancer.

Last year, the FDA approved only 22 new drugs, a sharp drop from the 45 that were given the green light in 2015. The 22 new medicines are the lowest number approved since 2010. There are several reasons for the decline, according to John Jenkins, director of the FDA Office of New Drugs. There were fewer drug applications filed before the FDA and the agency either delayed or rejected more applications last year compared to the prior 2 years. In addition, 5 drugs whose approval was expected in 2016 ended up winning approval in late 2015. Posted January 2, 2017. Via Reuters.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.

FDA Approves First Pill to Treat All Types of Hepatitis C

The FDA has approved the first drug to treat all 6 forms of the hepatitis C virus, though it won’t come cheap: A 12-week treatment course has a list price of $74,760.

Epclusa (sofosbuvir/velpatasvir) was approved to treat chronic hepatitis C virus (HCV), both with and without cirrhosis of the liver. Sofosbuvir, better known under its brand name Solvadi, was already approved back in 2013 to treat 4 genotypes of the HCV. Velpatasvir is an entirely new drug.

The approval of the combination pill, taken once a day, is considered a boost for patients because other oral HCV treatments require genetic testing to determine if a particular drug will work on them.

Epclusa was tested in 3 late-stage clinical trials that included more than 1,500 people with mild liver cirrhosis or no cirrhosis at all. Results indicated that between 95% and 99% of patients who received Epclusa had no HCV detected in the blood 12 weeks after finishing treatment, an indication the infection has been cured.

Side Effects

The most common side effects seen in these trials were headache and fatigue. However, Epclusa’s labeling also includes a warning that serious slowing of the heart rate, a condition known as symptomatic bradycardia, has occurred. Additionally, there are cases in which some patients have needed a pacemaker when sofosbuvir was used in combination with Corderone or Pacerone (amiodorone), a medication used to treat abnormal heart beat.

Epclusa’s label carries a warning not to use with certain drugs that may reduce the amount of Epclusa in the blood, which could minimize its efficacy. The other drugs include the anticonvulsant and mood stabilizer Tegretol (carbamazepine); Rifadin (rifampin), an antibiotic used to treat tuberculosis; and the herbal supplement St. John’s wort.

HCV affects between 130 million and 150 million people worldwide, according to the World Health Organization.

Jonathan Block
Jonathan Block

Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.